Are you ready to work for one of Washington's Top Workplaces? At Novavax, a clinical-stage vaccine company, we are creating tomorrow's vaccines today! We seek to attract, develop, and retain talented people who share our passion for science, medicine, and human health. We foster an environment of teamwork and collaboration, built on a culture that values and appreciates its employees. We are a fast-paced company that provides employees with opportunities to achieve personal and professional goals while also maintaining a balance between work and personal life.
We are seeking an Associate Director, Quality Systems to join our Quality Assurance Department. The Associate Director will be responsible for leading and developing the Documentation and Training functions within the Quality Systems Department. The position will be located at our Gaithersburg, MD facility and will report to the Director of Quality Systems.
Responsibilities include but are not limited to:
- Design, deployment and continuous improvement of Novavax cGMP Training Program.
- Design, deployment and continuous improvement of the Novavax Quality Assurance Documentation Program.
- Management and maintenance of Quality Systems to support product disposition of clinical trial materials.
- Create, track and assist in presenting metrics related to the Quality Management System for Senior Management.
- Participate in regulatory inspections and maintain a state of inspection readiness.
- Maintain working knowledge of Novavax Documentation (including Quality Manual, Policies and SOPs) and relevant GxP regulations and guidelines related to US and EU compliance.
- Management of staff.
- Other duties as assigned.
- Bachelor's degree in a scientific discipline
- 10+ years of Quality experience in pharmaceutical, biologics and/or vaccine manufacturing
- Minimum of 5 years supervisory experience
- Knowledge and expertise in principles and practices of current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP)
- Demonstrated verbal and written skills in communicating regulatory and technical information
- Solid organizational and time management skills, proven project management, presentation and facilitation skills.
- Biotechnology experience preferred.
- Innovation including looking internally and externally for best practices.
Additionally, we prefer candidates that have:
- The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems.
- The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision without neglecting attention to detail
- The ability to enable and drive change while being focused on internal and external customers.
- The ability to communicate well both verbally and in writing with all levels both inside and outside of the organization.
- Prior experience with electronic Learning and Documentation Management systems (deployment and maintenance)
- Capable to manage multiple priorities.
Novavax, Inc. (Nasdaq: NVAX) is a clinical-stage vaccine company committed to delivering novel products to prevent a broad range of infectious diseases. Our recombinant nanoparticles and adjuvant technology are the foundation for groundbreaking innovation that improves global health through safe and effective vaccines. Our product pipeline targets a variety of infectious diseases with vaccine candidates currently in clinical development for respiratory syncytial virus (RSV), seasonal influenza, pandemic influenza, and Ebola virus (EBOV). Novavax is headquartered in Gaithersburg, Maryland with additional facilities inRockville, Maryland and Uppsala, Sweden and employs over 300 individuals dedicated to developing novel vaccines to address infectious disease.
Novavax, Inc. offers a base salary, annual bonus, stock options, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.
We are an equal opportunity employer that values diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply.